Pharmacovigilance Associate

About the role

The Associate, Pharmacovigilance will monitor the safety of Hikma products and support a range of pharmacovigilance activities to ensure regulatory compliance.

Key responsibilities

• Follow all relevant department policies, processes, SOPs, and instructions.
• Monitor regulations and guidelines to detect pharmacovigilance updates.
• Assist in case processing, local literature searching, aggregate reporting, risk management, health risk assessment, product labeling reviews, and safety agreements for Egypt.
• Prepare PV documents such as aggregate reports, risk management plans, health risk assessments, and safety agreements to meet submission timelines.
• Support the implementation and evaluation of risk management plan activities in Egypt to ensure regulatory commitments are met.

Required profile

Required skills